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Our data is continuously updated and sourced from EUDAMED, the European database for medical devices and in vitro diagnostics.

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Penilex Silicone self-sealing urisheath — 30 UDI-DI variants, MDR

MD Atlas
Coloplast A/S

Data from EUDAMED, last updated May 23, 2026

Penilex Silicone self-sealing urisheath

57089322978419A

30 UDI-DI variants

MDR [Regulation (EU) 2017/745 on medical devices]Class I

Legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Risk class: Class I
Manufacturer: Coloplast A/S

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Device characteristics

No device characteristics flagged

Identity & classification

Basic UDI-DI: 57089322978419A
Device name: Penilex Silicone self-sealing urisheath
Issuing agency: GS1
Legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Risk class: Class I
Version date: Apr 1, 2026

Manufacturer & authorised representative

Manufacturer

Name: Coloplast A/S
SRN: DK-MF-000025526
Country: Denmark
Email: Eudamed_PA_Contact@coloplast.com
Phone: +4549111111

Variants by status

UDI-DI variants

30 UDI-DI variants

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Applied filters

basicUdiUlid01KN45BFH2ZR5PFRBTHCNQADYA

Format

Summary

29 columns included

Trade name
Basic UDI-DI
UDI-DI code
Risk category
Applicable legislation
Status
Organization name
SRN
Reference / catalog number
Additional product description
Intended medical purpose
Placed on the market (country)
Market info update date
Sterile
Single use
Contains latex
Reprocessed single-use
Direct marking
CMR substance
Endocrine disruptor
Annex XVI applicable
Sterilization
OEM applicable
EMDN codes
Last updated
Basic UDI-DI device name
Basic UDI-DI device model
Basic UDI-DI implantable
Basic UDI-DI reagent

PA702503600040252055
PA623003600040324615
PA502503600040251423
PA503203600040251522
PA703503600040252147

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